Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial

University College of Northern Denmark

Status: Enrolling

Conditions: Fibromyalgia; Adherence, Treatment; Stretch

Treatments: Other: Home-based stretching exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06487741

Fibromyalgia RCT

Details and patient eligibility

About

This randomised controlled trial will examine the clinical efficacy of a six-week, novel, home-based stretching programme compared to usual care on the effect of symptoms experienced by patients with fibromyalgia.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• individuals diagnosed with fibromyalgia in accordance with the ACR 2016 diagnostic criteria.
• individuals diagnosed with chronic non-malignant pain or individuals diagnosed with chronic widespread pain (including fibromyalgia syndrome) are also included when they meet the ACR 2016 diagnostic criteria.

Exclusion criteria

• Non-controlled systemic disorders (such as hypertension, diabetes and coronary insufficiency),
• neurological conditions that impair alertness or comprehension, musculoskeletal conditions that could compromise assessments (such as nerve root compression or knee joint inflammation),
• relevant joint disorders (such as severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis),
• recent changes in therapy for fibromyalgia (i.e., within four weeks of baseline).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day).

Treatment:

Other: Home-based stretching exercises

Control

No Intervention group

Description:

The control group receives usual care, and no change in treatment is made. Participants will be encouraged to maintain their daily routine but refrain from changing the current pharmacological treatment or initiating new physical exercise practices during the study.